Table of Contents

M 9 CBER, CFR 601.2, 314.50 Biologics Market Vol#: 1

SUP 1 CBER, CFR 601.2, 314.50 BLA, PLA, ELA, N Vol#: 1

95S-0158 Community Disclosure of Institutional Review Boards

SUP 21 Icos Corporation BB IND-7371 Vol#: 5

SUP 22 Icos Corporation BB IND-7371 Vol#: 5

98N-0313 Surgeons's and Patient Examination Gloves Reclassification

C 45 Karna Williams Vol#: 9

C 46 ASTM Vol#: 9

C 47 National Starch & Chemical Company Vol#: 9

C 48 MedicAlert Foundation Vol#: 9

C 49 ALERT Inc Vol#: 9

C 50 American Hospital Association Vol#: 9

C 51 Tillotson Healthcare Corporation Vol#: 9

C 52 Ansell Healthcare Products Inc Vol#: 9

C 53 London International Group Inc Vol#: 9

C 54 Johns Hopkins University School of Medic Vol#: 9

C 55 Spina Bifida Association of America Vol#: 9

C 56 Roquette America Inc Vol#: 9

C 57 HIMA Vol#: 9

C 58 Health Care Assocaition of NY State Vol#: 9

C 59 Latex Allergy News Vol#: 9

C 60 Public Citizen's Health Research Group Vol#: 9

C 61 Internat'l Association of Fire Fighters Vol#: 9

C 62 Barbara Zucker-Pinchoff, MD Vol#: 9

EMC 1 Dave Kinnaman Vol#: 9

99D-5424 Health claims for Conventional Foods & Dietary Supplements

REF 1 References Vol#: 2

99H-1179 Civil Money Penalties;Warner Ent Inc,d/b/a Alstead Village

LET 2 Office of Tobacco Programs Vol#: 1

99H-1955 Civil Money Penalty;Camellia Food Stores Inc,dba Be-Lo #121

LET 2 Office of Tobacco Programs Vol#: 1

99H-2191 Civil Money Penalty;Harold Myer & Linda H Myer,dba Rock Bluf

LET 2 Office of Tobacco Programs Vol#: 1

99H-3095 Civil Money Penalty;Holiday Food Stores Inc,dba Holiday Food

LET 2 Office of Tobacco Programs Vol#: 1

99H-4010 Civil Money Penalty;Route 3A Shell,dba Route 3A Shell

EXB 1 GCF-1 Vol#: 1

99H-4246 Civil Money Penalty;Jerry Conley,dba Conley's Country Corne

LET 2 Office of Tobacco Programs Vol#: 1

99H-4759 Civil Money Penalty;Thomas Seuferer,dba Elbow Room

LET 2 Office of Tobacco Programs Vol#: 1

99H-4945 Civil Money Penalty;Legus Service Inc,dba Andy Legus' Shell

LET 2 Office of Tobacco Programs Vol#: 1

WDL 1 GCF-1 Vol#: 1

99H-5254 Civil Money Penalty;Camisha Flowers; Yellow Store

LET 2 Office of Tobacco Programs Vol#: 1

WDL 1 GCF-1 Vol#: 1

99H-5468 Civil Money Penalty;Donovan Woodburn,dba Hop & Sack #18

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

99H-5494 Civil Money Penalty;George W.Klein,Jr;dba Tylers Tackle Shop

ANS 1 Tylers Tackle Shop & Crab House Vol#: 1

99H-5530 Civil Money Penalty;Don W. Haney Enterprises,Inc;dba Don's I

ANS 1 Don W Haney Enterprises Inc Vol#: 1

99H-5573 Civil Money Penalty;Belmar Avenues, Inc;dba Columbine Wines

ANS 1 Columbine Wines and Liquors Vol#: 1

99P-0485 Rescind Approval of Subtherapeutic Antibiotic Use Livestock

C 1941 Susan & Malvin Goodger Vol#: 174

C 1942 Jennie I. Rembold Vol#: 174

C 1943 Lenore Burgard Vol#: 174

C 1944 Dora Chang Vol#: 174

C 1945 BroadLink.com Vol#: 174

C 1946 Anna Peterson Vol#: 174

C 1947 Don A. Wilks Vol#: 174

C 1948 Robert Glatthaar Vol#: 174

C 1949 Carol D. Wolford Vol#: 174

C 1950 Heather M. Cartwright Vol#: 174

C 1951 Kaete R. Eisenmann Vol#: 174

C 1952 Mrs. Geneva King Vol#: 174

C 1953 Nisha Dawson Vol#: 174

C 1954 Dr. Douglas E. Wingeier Vol#: 174

C 1955 Mrs. Carol Burdick Vol#: 174

C 1956 Barbara Bonsignore Vol#: 174

C 1957 Jenise Porter Vol#: 174

C 1958 Diana Moreton Vol#: 174

C 1959 Roy C. Rineer Vol#: 174

C 1960 Sara Chenoweth Vol#: 174

C 1961 Nikki Boccaleoni Vol#: 174

C 1962 Linda Scullary Vol#: 174

C 1963 Mark M. Giese Vol#: 174

C 1964 Laurie E. Casserly Vol#: 174

C 1965 Frances E. Harkins Vol#: 174

C 1966 Elaine Douglass Vol#: 174

C 1967 Alan William Fortescue, M.A. Vol#: 174

C 1968 Melissa J. Doll Vol#: 174

C 1969 Diane Kyser Vol#: 174

C 1970 Clyde W. Burnham, Ph.D. Vol#: 174

C 1971 Charlotte Hari Vol#: 174

C 1972 Suzanna Bortz Vol#: 174

C 1973 Kristine Erickson Vol#: 174

C 1974 Peggy Clark Lumpkins Vol#: 174

C 1975 Carol Frith Vol#: 174

C 1976 Edmond Greenberg Vol#: 174

C 1977 Janet V. Sappington Vol#: 174

C 1978 Mrs. Mary L. Lein Vol#: 174

C 1979 Alberta Burns Vol#: 174

C 1980 Winnie Dushkind Vol#: 174

C 1981 Denise Cohn Vol#: 174

C 1982 Cindy Charleville Vol#: 174

C 1983 Mary Boyle Vol#: 175

C 1984 Mary Becelia Vol#: 175

C 1985 Beauty Without Cruelty U.S.A. Vol#: 175

C 1986 Zubrensky Padden Horwitz & Weir Law offi Vol#: 175

C 1987 Deborah L. Hileman Vol#: 175

C 1988 Virginia T. Stott Vol#: 175

C 1989 Peter D. Burzenn & Mayo Alexander Vol#: 175

C 1990 Elizabeth S. Barberi Vol#: 175

C 1991 Scott M. Foster Vol#: 175

C 1992 Ms. Geraldine A. Vokoun Vol#: 175

C 1993 Alan W. Town Vol#: 175

C 1994 Mary Jane Yoder Vol#: 175

C 1995 Lisa W. Gardner Vol#: 175

C 1996 Sabel Regalia Vol#: 175

C 1997 Jennifer L. Martin Vol#: 175

C 1998 Helen Thomas Vol#: 175

C 1999 Marilyn McKinley Vol#: 175

C 2000 Best Western Capinteria Inn Vol#: 175

C 2001 Carol & Gary Boos Vol#: 175

C 2002 Julie Schroer Vol#: 175

C 2003 Mr. & Mrs. Robert E. Balster Vol#: 175

C 2004 Sandra Weissfisch Vol#: 175

C 2005 Sherrita Carter Vol#: 175

C 2006 110 Signatures Vol#: 175

C 2007 Mrs. Robert J. Lehman Vol#: 175

C 2008 Valerie Dambacher Vol#: 175

C 2009 Linda J. Meyer Vol#: 175

C 2010 Karen Parker Vol#: 175

C 2011 Debbie Uterstaedt Vol#: 175

C 2012 Patricia C. Winckler Vol#: 175

C 2013 Anthony Cammarano Vol#: 175

C 2014 Mary E. Hoffmann Vol#: 175

C 2015 Bill Anderson Vol#: 175

C 2016 Doris Applebaum Vol#: 175

C 2017 Augustin H. Parker Vol#: 175

C 2018 Barbara & Vic Ulmer Vol#: 175

C 2019 Arthur R. & Lynn Mink Vol#: 175

C 2020 Marjorie T. Duck Vol#: 175

C 2021 Joan M. Mittelstaedt Vol#: 175

C 2022 Florence Meier Vol#: 175

C 2023 Agnes Eanes Vol#: 175

C 2024 Jennifer Leeman Vol#: 176

C 2025 Kelly Lindgren, Ph.D., RN Vol#: 176

C 2026 A Moving Experience Vol#: 176

C 2027 Margery Hughes Vol#: 176

C 2028 Moriah Nelson Vol#: 176

C 2029 Maria Sarath Ragucci Vol#: 176

C 2030 Tara Mize Vol#: 176

C 2031 no signature Vol#: 176

C 2032 Donna & Jack Salem Vol#: 176

C 2033 10 signatures Vol#: 176

C 2034 Rosaleen Vol#: 176

C 2035 Jan Kelley Vol#: 176

C 2036 Professional Nutrition Services Vol#: 176

C 2037 Teri Ashley Vol#: 176

C 2038 Lynn & Harrison Houston Vol#: 176

C 2039 Elise Andrews Vol#: 176

C 2040 Bernice Smith Vol#: 176

C 2041 Jill McGrath Vol#: 176

C 2042 Iowa Methodist Medical Center Vol#: 176

C 2043 Janet A. Moore Vol#: 176

C 2044 Ms Joyce Frohn Vol#: 176

00H-0005 Civil Money Penalty;Naser Arnaout,dba Norman Market

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

00H-0013 Civil Money Penalty;Ted Daniels and Gus Daniels,dba Pronto D

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

00H-0015 Civil Money Penalty;Bill Emison,dba Holiday

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

00H-0065 Civil Money Penalty;Go-Mart Inc,dba U-Pak Food Store

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

00H-0080 Civil Money Penalty;Stephenson Service Company,dba FS Fast S

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

00H-0180 Civil Money Penalty;Zahid Feroz;dba Harford Amoco

LET 2 Office of Tobacco Programs Vol#: 1

00H-0203 Civil Money Penalty;Stokes Enterprises,Inc;dba Stokes Thrift

ANS 1 Stokes Ents Inc,dba Stokes Thrifway Vol#: 1

00H-0300 Civil Money Penalty;Hop & Sack Convenience Store #1 LLC,dba

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

00H-0359 Civil Money Penalty;Danh duy Pham,dba Carol Sue Quick Stop

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

00H-0360 Civil Money Penalty;Swencorp Inc,dba Swensen's Food & Drug #

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

00H-0361 Civil Money Penalty;Fearless Farris Service Stations Inc,dba

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

00H-0362 Civil Money Penalty;Wal-Mart Stores Inc,dba Wal-Mart Superce

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

00H-0363 Civil Money Penalty;Wal-Mart Stores Inc,dba Wal-Mart #0441

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

00H-0364 Civil Money Penalty;William James Lear,dba Downtown Tobacco

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

00H-0365 Civil Money Penalty;Maverik Country Stores Inc,dba Maverik C

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

00H-0366 Civil Money Penalty;Zip-Fer Gas & Grocery Inc,dba Zip-Fer Ga

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

00H-0367 Civil Money Penalty;Johnson's IGA Inc,Lexington IGA

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

00H-0368 Civil Money Penalty;Owings Incorporated,dba Southside Foodto

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

00H-0369 Civil Money Penalty;Tevis Oil Inc,dba Jiffy Mart of Hampstea

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

00H-0370 Civil Money Penalty;Kins Foodmart Inc,dba Kins Foodmart

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

00H-0371 Civil Money Penalty;Franconia Shell Inc,dba Franconia Shell

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

00H-0372 Civil Money Penalty;Walco Service Inc,dba Hampstead Walco Se

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

00H-0373 Civil Money Penalty;Carter & Hollowell Inc,dba Carter & Holl

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

00H-0374 Civil Money Penalty;Safeway Inc,dba Safeway Store #1285

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

00H-0375 Civil Money Penalty;Gas City Ltd,dba Gas City #87

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

00H-0376 Civil Money Penalty;Duane Moren & Susan Moren,dba Y Grocery

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

00H-0377 Civil Money Penalty, Mountain West Enterprises Inc,dba Mount

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

00H-0378 Civil Money Penalty;James Howell,dba Howell's Big Store

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

00H-0379 Civil Money Penalty;Casey's Marketing Company,dba Casey's Ge

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

00H-0380 Civil Money Penalty;High's of Baltimore Incorporated,dba Hig

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

00H-0381 Civil Money Penalty;JGDC Inc,dba House of Liquors

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

00H-0382 Civil Money Penalty;Rehman Inc,dba Stop 1

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

00H-0383 Civil Money Penalty;Richard A Bosnick Sr,dba 7-Eleven Store

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

00H-0384 Civil Money Penalty;S7J Ham Inc,dba Norman's Liquor Store

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

00H-0385 Civil Money Penalty;Traband Enterprises Inc,dba Victory Vill

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

00H-0386 Civil Money Penalty;William R Kerr,dba Ellicott General Stor

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

00H-0387 Civil Money Penalty;Bedford Corporation and Joyce Nalle,dba

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

00H-0388 Civil Money Penalty;Foodmark Stores Inc,dba Cub Foods #9433

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

00H-0389 Civil Money Penalty;Smokey Bear Inc,dba Smokey Bear

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

00M-0424 PMA SVS Apex Plus Excimer Laser Workstation, Emphasis Discs

AAV 1 Summit Technology Inc Vol#: 1

00V-0496 Laser Light Show

VAR 1 Advanced Lighting & Production Services Vol#: 1